Recalls / Class II
Class IID-0387-2025
Product
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 51991-746, 51991-747, 51991-748, 51991-750
- FDA application
- ANDA203088
- Affected lot / code info
- Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, N/A, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- 16,473 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-04-14
- FDA classified
- 2025-04-22
- Posted by FDA
- 2025-04-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0387-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.